Ultragenyx Pharmaceutical
Biopharmaceutical
Director,CMCQA
Neural analysis suggests this role is
optimal for Director candidates.
“Director, CMC QA at Ultragenyx Pharmaceutical. Skills: CMC Quality, GMP Manufacturing, External Quality Assurance. Review/approve investigation of operations. Lead strategic discussion for investigations”
What You'll Achieve.
Ensure product quality; Meet cGMP regulatory requirements
Industry & Context.
Root cause analysis; Creative solutions
10% travel
What They're Looking For.
Must Have
Bachelor's degree in Engineering, Biotechnology, Biological/Physical sciences, or equivalent, 10+ years GMP biopharmaceutical manufacturing experience, Working knowledge of FDA, EMA, local regulations, Working knowledge of Good Distribution Practices, Working knowledge of ICH guidelines, Working knowledge of industry best practice, Experience using risk management tools, Experience performing technical assessment of changes, Capability of engaging with Contract Organizations, Experience in biologic and small molecule drug development, Demonstrated high personal and professional ethical standards, Excellent judgment, Ability to think and act quickly, Ability to identify creative solutions, Ability to interpret and relate Quality standards, Ability to communicate clearly and professionally, Organizational and project management skills, Track record of meeting goals/objectives, Experience with regulatory authority inspections
Nice to Have
Master's degree preferred, Experience with mRNA therapeutics
What You'll Do.
Review/approve investigation of operations
Lead strategic discussion for investigations
Oversee resolution of quality events
Monitor recurrent events escalation
Ensure root cause is determined
Evaluate impact on product quality
Implement corrective actions
Review and approve changes
Perform final review of test data/reports
Drive execution of risk assessments
Manage product lifecycle
Address qualification requests
Engage with Tech Development
Address process development requests
Develop and maintain procedures
Maintain practices in compliance with regulations
Perform other duties as assigned
How You'll Work.
Team & Collaboration
External partnerships; Key stakeholders; Technical Operations; Tech Ops; Tech Development
Communication Scope
Written communication; Verbal communication
Process & Methodology
Project management
Full Job Description
Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won’t go – challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth – so employees can thrive in all areas of their lives, in and outside of work. Ultimately, we want to be an organization where we would be proud for our family, friends and children to work. If you want to have a meaningful impact, do the best work of your career, and grow a lot, both professionally and personally, come join our team. Position Summary: ultrafocused – Work together to fearlessly uncover new possibilities The Director, CMC QA will report to the Senior Director of CMC QA and be responsible for maintaining strategic responsibility over QA Manufacturing Operations, developing and implementing Ultragenyx CMC Quality approach for assigned programs, and working with colleagues to improve processes utilized to ensure product quality. In addition, this position will use strong management skills to independently manage external partnerships. In this role, in collaboration with key stakeholders in Technical Operations, DIR CMC QA provides quality oversight and support to ensure clinical through commer
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